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The intended use for the manual (mechanical) wheelchair is to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. All other uses are prohibited.

A mechanical wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. Wheelchairs are used by people for whom walking is difficult or impossible due to illness, injury, or disability. The device is intended for adults only. As oppose to the standard wheelchair properties, the Supertilt Tilt main feature can tilt in space for up to 33 degrees using two gas cylinders that can support up to 250 lbs. The components include frame, back upholstery, seat upholstery, handgrip, armrest, armrest pad, side panel. In terms of biocompatibility, the main direct contact components on long periods in time with the user/client are the arm rest pad, cushion back cushion, headrest pad and footrest padding. Transient contacts with the user/client include arm skirt guard, arm tube, arm socket and footrest tube. The Supertilt Plus in its final finished form is identical to the Concept 45, Invacare, K951138, cleared on 3/20/1995 (legally US marketed device) in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers. device) in formulation, processing, sterilization, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).

The provided text describes the 510(k) premarket notification for a mechanical wheelchair, the "Supertilt Plus (STP)". It details the device's characteristics, its intended use, and a comparison to a predicate device (Concept 45, K951138). However, it does not contain the specific information required to answer your detailed questions about acceptance criteria, study methodologies, expert involvement, and ground truth for an AI/ML medical device.

The document is for a mechanical wheelchair, which falls under a different regulatory pathway and testing requirements than an AI/ML diagnostic or prognostic medical device. The "testing" mentioned refers to mechanical and design standards (e.g., ISO 7176 standards, ANSI/RESNA), not performance metrics related to AI algorithm accuracy, sensitivity, or specificity.

Therefore, I cannot extract the requested information using the provided text.

Specifically, the following information is missing from the document for an AI/ML device:

1. A table of acceptance criteria and the reported device performance: This would typically include metrics like sensitivity, specificity, AUC, etc., which are not applicable to a mechanical wheelchair.
2. Sample size used for the test set and the data provenance: Information on data collection (e.g., image sets, patient records) for an AI model is absent.
3. Number of experts used to establish the ground truth and their qualifications: There's no mention of experts interpreting data for ground truth, as this device is a physical product.
4. Adjudication method for the test set: Not applicable for a mechanical device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is for evaluating human performance with and without AI assistance, which is not relevant for a mechanical wheelchair.
6. Standalone (algorithm only) performance: No algorithm is described.
7. Type of ground truth used: No diagnostic ground truth is relevant.
8. Sample size for the training set: No AI model training is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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